Container closure



Oct. 24, 1961 E, J POITRAS ET AL 3,005,455

CONTAINER CLOSURE Filed June 24, 1955 2 Sheets-Sheet 1 E291. Eagle/ya.

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CONTAINER cLosURE Filed June 24, 1955 2 Sheets-Sheet 2 Biggs.

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{[Pazffws, Caad WWaZe, y M @ma f/wwd; @www eBay@ 3,005,455 CNTAiNERCLOSURE Edward l. Poitras and Carl W. Walter, Holliston, Mass.,assignors to Baxter Laboratories, inc. Filed .lune 24, 1955, Ser. No.517,742 S Claims. (Cl. 12S- 272) This invention relates generally toapparatus for sealing or closing iluid containers, and more particularlyto closure or stopper devices such as adapted to the dispensing as wellas to the sealing of fluid from and in such containers. The closure ofthe invention is intended and adapted particularly for use with medicaland other uids which are required to be stored and also dispensed insterile condition. The invention aims generally to provide an improvedcontainer closure providing novelly for the automatic venting of thecontainer subject t positive container pressure, as duringsterilization, and subject also to container vacuum, as duringdispensing, while preserving the container fluids sterile sealed againstcontamination in handling and storage. The further object of theinvention is to provide fiuidhandiing apparatus specially formed andfitted for the safe compounding or combining of component iluids in andas a sterile mixture. The invention aims still further to provide acontainer closure affording the mixing of a specialized solution intoand conjointly with the dispensing or administering of such solution outof a uid container. The invention will be better understood from aconsideration of the following specification taken in conjunction withthe accompanying drawings inwhich:

PIG. 1 is a top plan of a closure of the invention;

FIG. 2 is a section along the line 2-2 of FIG. l and showing the closureinstalled on a container;

FIG. 3 is a top plan of a modified form of the closure;

FIG. 4 is a section along the line 4--4 of FIG. 3`

and showing the FIG. 3 closure installed on a container;

FIG. 5 shows a fluid conduit or container coupler device as employedwith the invention apparatus; and

FIG. 6 is an elevation, partly in section, of a container pair fittedwith the invention closures and coupled for fluid mixing.

ln medical and hospital practice parenteral, intravenous and the likemedical fluids or liquids are commonly readied and stored in closedcontainers from which they may be supplied for administering directly toa patient. These containers or bottles are required to be kept sterileand hermetically sealed at least during storage and desirably alsoduring such fluid administering.

The present invention improves upon the prior iiuid handling andadministering practice by providing novelly for the combining orcompounding of specialized mixtures and solutions, as just prior to orcoincident with the uid administering, in desired sterile preservingmanner. More particularly, full or fractional volumes from one or morecomponent or concentrate bottles may be added or combined in a mixtureor solution bottle Without mess or drip and without violating contentsterility.

Our invention provides also an improved closure apparatus novellypromoting the described handling or combining of medical fluids inaccordance with accepted hospital techniques. The stopper of theinvention is described rnore particularly as uniquely adapting orcoupling iiuid containers for safe sterile administering or combining oftheir solutions.v Our novel closure will be understood further toincorporate self-venting, selfsealing features permitting the safesterilization of as well as the sterile administering from a containerstoppered by the same.

T he invention closure or stopper comprises in the embodiment of FIGS. land 2 a rubber or other elastic bush- Patented Oct. 24, 1961 ing havinga central annulus or waist 10 which may be tapered or otherwise shapedor proportioned for seating or seizing in the opening or mouth of thecontainer or bottle B. The bushing Waist 10 is apertured to provide anaccess or llling and dispensing passage or opening 11 and spacedtherefrom Ia primary inlet or venting passage or opening 12. v

in accordance with the invention the bushing 10 may be variously ttedfor vacuum or negative pressure openable closure of the vent opening 12,as herein by the valve 13 yieldably biased against the same and definedmore particularly as Ia cup-shaped projection integrally dependent fromwaist 1li and characterized by a thin vertical side wall 13a supportingand capped by lateral bottom wall 13b. A lateral slit 13e is cut througha substantial portion of the periphery of the valve 13 and in the planeof the side-bottom wall juncture, whereby bottom wall 13b is dened as aflap depressible from the normal vent closing position shown.

The upper face or margin of the bushing waist 10 is seen to mount alateral or radial projection or web 14 yadapted for engagement over thecontainer rim, as shown. Medially supported from this web 14 is avertical sleeve 15 deiining downwardly a skirt 16 for clamping about theneck of the bottle B and upwardly a coupler or coupling element orprojection 17. The coupling projection 17 is herein shown to comprisemore particularly a waist enclosing flange or lip spaced and projectinginwardly over the web 14 and mounting at its under face a sealing ring17a.

in accordance with the invention the bushing 1t) isv ing or base portion12 and centrally thereof a vertical manipulating or stem portion 20. Thebase 19 is seen to be shaped and proportioned, as with a bevel 19a, forreleasably clamping under bushing lip 17, and more particularly forsealing engagement between lip ring 17a and a like waist mounted sealingring 10a projecting opposite said lip ring 17a and about bushingopenings 11, 12.

The FIGS. 1 and 2 closure or stopper cap comprises further a verticalopening 21 extending through base and stem portions 19, 2li and adaptedto align with the bushing access opening 11, as shown. This cap opening21 is closed at its upper end by an elastic plug 22 undercut orotherwise formed to deiine a partible or puncturable wall or diaphragm.The diaphragm 22 is seen to be sterile-sealed by a conventional tear tab23 engaged in' known manner over the stem 20.

Further in accordance with the invention, our improved closure isnovelly fitted for venting the container automatically responsive to thebuild up of positive pressures, Ias during sterilization, and thensealing the container automatically upon the development of negativepressure, as in the subsequent cooling of the same. As herein embodiedthis positive pressure sensitive vent valve means comprises a slit 24cut through bushing sleeve 15 at the base of lip 17 and radially outwardof cap base 19. The valve slit 24 will be understood to be formed by thecutting or parting of, but not the removal of material from the sleeve15, and hence normally to be closed as shown. The opening or parting ofthe valve or slit 24 is thus seen to require the distension of sleeve15, as by the lifting or forcing oi the cap 18 from the bushing 10.-

The stopper bushing may be installed before or after filling or chargingthe container or bottle B with the desired quantity of medical or otheriiuid or solution. The filled container is closed and sealed by theinstallation of the cap 18 which may be grasped by the stem 20 andmanipulated so as to snap the base 19 in place under bushing lip 17, asshown. The bottle, iiuid and closure are then subjected to desiredsterilization. As already noted, the expansion of the container fluidsor gases under sterilization heat will develop a positive containerpressure sulicient to lift or force cap base i9 from its sealing seat10a, whereby the excess container pressure is dissipated through ventvalve 24. The instantaneous automatic closing of slit 24 is seen to beaccomplished by the return of cap i3 to its seat or ring 10a under theclamping action of lip 17, whereby the container is closed against airingress, and the container fluids are preserved in sterile,vacuum-sealed condition.

The closure of the invention is quickly and easily manipulated fordischarging the contents of the bottle B. The usual dispensing, asthrough a iiuid administering set, merely requires the snapping orrocking of the cap i8 free of its engagement under bushing lip 1?'. Thedesired duid conducting or administering means are then fitted orseated. at bushing opening 11 and the bottle B inverted or otherwisearranged for gravity or other ow of its uid charge or solution. Suchdispensing flow will be understood to be permitted by the check valve i3which, while normally closing vent opening l2, opens automaticallysubject or sensitive to a dierential or negative pressure across or atthe flap 13b.

It will be appreciated also that the bottle B may be lledthrough thebushing l0 and more particularly through either of the passages 1i, l2.Where the access passage 11 is employed for filling, the valve i3 may beopened as by inserting an adaptor o-r the like through the passage 12and, dispensing flap 13b, to permit required iuid or air egress. Itshould be noted in this connection that check valve 13 is speciallyformed to permit its retraction as necessarily incident to the deectingof ap 13b as just described. More particularly, the valve side wall 13a,which acts as a resilient hinge, projects outwardly or downwardly of themain body of the bushing 1) so as freely to permit such lateraldisplacement or folding retraction of the same as accompanies thesimilar shifting of the bottom wall i312.

Further in accordance with the invention, the FIGS. l and 2 stopper isadapted novelly for introduction of additional fluid into the vacuumsealed container B without violating the sterility of its contents. Suchiluid addition merely requires the removal of the tear tab 23 and thepiercing of the diaphragm 21 by a syringe, needle or the like pointedlluid conduit means.

It will be understood that various forms and constructions of thestopper elements, and more particularly the cap and positive andnegative pressure-sensitive vent means are comprehended by theinvention. Considering now more particularly FIGS. 3 and 4, ourinvention stopper is there shown to comprise a bushing having a. waist30 shaped and proportioned for a loose or clearance tit in the mouth ofthe bottle B, as shown. The stopper bushing has spaced vertical accessand vent openings 31 and 32 therethrough, and about vent opening 32 anannular or other integrally dependent projection 33 constituted as anegative pressure sensitive check valve by a lateral slit 33a cutthrough a substantial portion of the same and in the plane of itsjunction with the bushing main body. Integrally and radially extensiveof the bushing 30 is a web 34 and medially supported therefrom avertical collar or sleeve 3S incorporating a skirt 36 and an upstandinginturned coupler flange or lip 37.

The FIGS. 3 and 4 closure comprises further a solid, unitary cap 38comprising a at base 39 and centrally thereof an upstanding manipulatingstem 4t). The cap is seen to be clamped between the lip 37 and anannular or other bushing rib or seat 30a projecting about the openings31, 32. The stopper is iitted for self-venting by a groove 41 formed inthe under face of skirt 36, and extending upwardly over the lip of thebottle and inwardly part way across web 34, and stopping short of orout- 17,1 side the inner wall of the bottle mouth, or as clearly shownin FIG. 4.

The operation of the FIGS. 3 and 4 closure will be understood to begenerally similar to that already described for the FIGS. 1 and 2embodiment. Thus the loose tting waist 30 is seen as readily lifted, asby sterilization pressures, to permit venting of the bottles throughgroove 41. It should here be noted that the several stopper cap and ventforms may be variously combined without departing from the scope andspirit of the invention, andv not only by the substitution but also bythe addition of the parts. Thus the invention stopper may be providedwith plural positive pressure vent means, as by adding a valve slit likethat shown at 24, FIG. 2 to the FIGS. 3 and 4 form.

The improved fluid handling and administering techniques made possibleby the invention apparatus are illustrated in FIG. 6. As already notedthe stopper can in both its embodiments be employed for simpleadministration of the contents of the bottle by merely tipping andremoving the cap. It may, however, be desired to compound more complexsolutions, as by adding a small bottle of, say, a desired concentrate toa large bottle of, say, dextrose. This may be accomplished under theinvention by coupling the bottles through duid conduit means of the typeand in the manner now to be described. The solution compoundingapparatus of FIG. 6 is seen to comprise a small bottle Sil fitted with astopper 52 of the FIGS 3, 4 type, with cap removed, and a large bottle51 plugged by a stopper 53 of the FIGS. 1 and 2 type, andwi'th cap insealing position. The bottles Sil, 51 are seen to be coupled orconnected by fluid conduit means fitted at one end for sealed seating inthe access passage 54 of stopper 52 and at the other for insertionthrough the stopper 53.

Such means may comprise any suitable tubular adaptor or uid conduitmeans such as a hypodermic needle 6u, FIG. 5, commonly formed at itsopposite ends with a seating hub 6l and a stem or cannula 62 terminatingin a piercing or puncturing point, as shown. The needle 60 may be keptsterile-sealed by plastic sealing sheaths 63, 64 drawn over and seizedto the hub and cannula respectively. In assembling the apparatus of FIG.6 the sheath 63 is tirst removed from needle ou, and the needle 60 isthen applied to the stopper so as to seize and seat hub 61 in accessopening 54, as shown. The sterile tear tab is then removed from cap 5Sof stopper 53 and the needle cannula 62 forced through diaphragm 57 anddownwardly into bottle-sealing position, as shown. It will beappreciated that the vacuum present over the solution in the largebottle 5l will draw in the fluid supplied from the small or concentratebottle Sti, and that the necessary venting of air into the small bottleis permitted by the operation of the automatic vent valve 56. It will beunderstood further that the fluid volume thus transferred may becontrolled or determined by the removal of the needle 60 after thedesired amount has been transferred, and that several component uids orsolutions may be combined as desired by repeating the process justdescribed. Again, all or less than all of the contents of one or morethan one component bottle may be combined to compound any desiredmixture or specialized solution.

Our improved technique for tailoring solutions to the varying needs ofindividual patients will be seen therefore to reduce substantially thestorage requirements of hospital supply rooms and the like.

It will be appreciated also that the invention apparatus is adapted fortandem hookup, wherein two or more con-tainers may be connected as fordispensing, cornbined or adding their contents, for and during iluidadministering. Thus a first bottle may be tted with a stopper andadministering set coupled at the stopper access opening, and a second,stopper-fitted bottle may be connected to the first by a transfer sethaving its one end installed at the access opening of the second bottlestopper and its other end received through the vent opening of the firstbottle stopper. It will be appreciated that with the `describedarrangement the uid being administered is preserved sterile-sealed, andits ow is permitted by the self-venting of the system, and moreparticularly of the second bottle stopper, similarly as with theapparatus of FIG. 6.

Our invention is not limited to the particular embodiments thereofillustrated and' desired herein, and we set forth its scope in ourfollowing claims.

We claim:

1. A self-sealing closure for a container having an open mouthcomprising in combination an elastic bushing adapted to plug thecontainer mouth and having access and venting passages, valve means onsaid bushing and normally closing the venting passage, said valve meansautomatically operable to open said venting passage subject todifferential pressure thereat, and a separable cap sealing the accesspassage and formed with a passage aligned with said access passage andclosed by a puncturable diaphragm.

2. A self-venting closure for a container having a mouth comprising astopper adapted to be applied to said mouth and having an opening, a capover said opening, a coupler on said stopper and surrounding andsealingly engaged over said cap, and a normally closed vent valve onsaid coupler, said valve opening subject to the forcing of said cap fromsaid opening.

3. A closure according to claim 2 wherein said coupler comprises anintegral elastic ange and said valve is dened by a slit through saidange.

4. A container closure comprising a cap and a bushing, said bushinghaving :access and venting openings and formed also with lan elastic lipsurrounding and yieldably clamping said cap over said openings, said lipformed outwardly of said cap with a slit parted by the forcing of thecap from said openings.

5. A container closure according to claim 4, and vacuum sensitive valvemeans normally closing fthe venting opening.

6. A container closure comprising an elastic bushing having an accessopening and a lip projecting about said opening, and a cap having amounting portion clamped under said lip and a manipulating portionsupported over said opening, said manipulating portion formed with athrough passage aligned with the opening and closed by a pierceableplug.

7. .A container closure comprising an elastic bushing having an accessopening -and mounting a coupling element surrounding said opening, a caphaving a mounting base clamped under said element and a manipulatingstem supported over said opening and formed with a through passage, 1apuncturable diaphragm closing said passage, and a tear tab over saiddiaphragm.

8. A closure for a fluid container having an open mouth comprising abushing adapted to be seated in the container mouth and having accessand venting openings, a valve normally closing the venting opening, saidvalve opening automatically subject to a negative pressure in acontainer in Whose mouth said bushing is seated', a cap over the accessopening, bushing carried means releasably clamping said cap to saidaccess opening, said means -automatically shifting to permit the liftingof said cap from said opening subject to a positive pressure in acontainer in whose mouth said bushing is seated, and a normally closedvalve in said cap clamping means, said valve opening automatically uponsaid shifting of said mea-ns to permit the lifting of said cap.

References Cited in the le of this patent UNITED STATES PATENTS1,694,851 Glass Dec. 11, 1928 2,191,495 Nesset Feb. 27, 1940 2,202,163Mulford May 28, 1940 2,338,140 States Ian. 4, 1944 2,452,644 Fields Nov.2, 1948 2,603,218 Rane July 15, 1952 2,616,581 Madsen Nov. 4, 19522,688,326 Lerman Sept. 7, 1954 2,713,953 Jewell July 26, 1955 2,735,565Wheaton Feb. 21, 1956 2,742,170 Bramming Apr. 17, 1956 2,757,670 OgleAug. 7, 1956 FOREIGN PATENTS 458,274 Germany Apr. 2, 1928 971,839 FranceAug. 16, 1950

